A specialty clinical-stage pharmaceutical company in Israel is preparing to conduct the next trial phase for a cannabinoid-based Alzheimer’s disease treatment.
Tel Aviv-based SciSparc on Wednesday announced the signing of an agreement with the Israeli Medical Center for Alzheimer’s (IMCA) to conduct a Phase IIa clinical trial for SCI-110 (formerly THX-110).
The SciSparc trial will evaluate the safety of SCI-110, its tolerability, and its ability to quell behavioral disturbances like agitation and aggression in patients.
The SCI-110 formulation combines synthetic delta-9 tetrahydrocannabinol, also known as Dronabinol, with palmitoylethanolamide (PEA).
In clinical studies, PEA has shown potential as an effective pain reliever with a notable lack of side effects.
Board-certified geriatrician and Principal Investigator Dr. Alona Raveh, MD will lead the study, “Clinical Study Protocol Phase II-a open label trial to evaluate the safety, tolerability, and efficacy trend of SCI-110 in patients with Alzheimer’s Disease and agitation.”
IMCA CEO Nitai Eliash says that as the world population ages, Alzheimer’s disease is one of the most common diseases affecting the elderly.
“Alzheimer’s disease is frequently associated with neuropsychiatric symptoms such as agitation and aggression, especially in the severe stages of the illness,” says Eliash. “However, the limited efficacy and high-risk profiles of current pharmacotherapies for the management of agitation and aggression in Alzheimer’s disease left us, the caregivers, with no good treatment alternatives. We are always in the search for new, innovative treatment solutions, and I hope SCI-110 may represent such a solution.”
Alzheimer’s disease, the most common cause of dementia, is a progressive neurological disease that causes the brain to shrink.
Early symptoms of Alzheimer’s disease include lapses in memory regarding recent events and conversations.
As the disease progresses, memory impairment becomes more severe.
Complications, such as dehydration and infection, stemming from severe loss of brain function in the advanced stages of Alzheimer’s disease result in death.
Currently, there is no treatment that cures Alzheimer’s disease.
“We believe there is strong scientific rationale for exploring SCI-110 in patients with Alzheimer’s disease and agitation,” says SciSparc CTO Dr. Adi Zuloff-Shani Ph.D. “And we appreciate very much the collaboration and opportunity to study our innovative proprietary drug candidate, SCI-110, and the leading center in Israel for the treatment of Alzheimer’s disease patients.”
SciSparc will initiate the Phase IIa study after receiving approval from the Institutional Review Boards and the Israeli Ministry of Health.
